QC Drug Product Technologist

Job Description

A QC Drug Product Technologist is required for a Pharmaceutica site based in Dublin. The main duties of this role are to perform the analysis of samples and to perform troubleshooting as required.

This QC role offers great exposure to a range of analytical methods ensuring that the successful candidate gets as much cross functional experience as possible. There is also scope to be involved in continuous improvement projects

This company pride themselves on providing a clear career pathway and development plan for each employee, with opportunity for further internal and external training.

Main responsibilities / job expectations

• Analysis of Drug Product batches according to approved analytical SOPs and as per relevant specification. This may include any of the following techniques (and is not limited to): Microbiological test methods such as Endotoxin and Sterility testing, ELISA, UV, Karl Fischer, pH, HPLC and Sub Visible Particulates.
• Perform activities to support the daily test schedule include media release testing and cleanroom preparation for Sterility testing.
• Training must be completed as per relevant training modules and supported with external training courses as required. The Technologist must become knowledgeable in all analytical techniques performed. Attend training in relevant manufacturing locations as required. The QC Drug Product (QC DP) Technologist must support the training of new staff and provide support to other Technologists.
• Results are compiled and submitted for review in a timely manner and it is important that attention is paid to the detail of the SOP and documentation.
• The QC DP Technologist must raise any Unplanned Events or Out of Specification results in a timely manner following discussion with Senior personnel and must inform the Senior personnel immediately of any such events. The QC DP Technologist must inform the Manager/Senior personnel of any issues as they arise, which may impact on the test and release schedule.
• Laboratory practices must promote accuracy and precision in daily laboratory routines.
• Laboratory Equipment must be calibrated in accordance with the schedule.
• Complete activities for Inspection readiness.
• Purchasing of laboratory consumables and reagents required to support testing.
• Generate SOPs, test methods, risk assessments and other documentation as required.
• Adherence to the company safety and environmental policies during analysis.
• Liaise with personnel at other manufacturing facilities to ensure accurate transfer of information and for troubleshooting any issues as they arise.
• Co-ordination of sample and reference standard shipments to Dublin
• Knowledge sharing to ensure both sites are aligned, and procedures are harmonised.
• Integrated approach within the Laboratory, supporting EE initiatives (e.g. 5S).
• Ensure high standards of housekeeping are maintained in the area.
• Complete all training assigned in a timely manner.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

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